Senior CSV QA Lead – GxP Systems, AI Governance, Hybrid

Socket.dev; San Francisco (CA); Hybrid; USD 145,000 - 170,000; Full time

Benefits offered by this job

Hybrid work model

401(k) with employer match

Employee stock purchase program (ESPP)

Pre‑tax commuter benefits

Referral bonus

Subsidized lunch and parking

Medical, dental, vision coverage

Job summary

BridgeBio is seeking a Senior Manager, Computer System Validation (CSV), QA in California to oversee the validation lifecycle for GxP systems. You will partner with IT, QA, and business process owners to ensure systems remain compliant and validated throughout their lifecycles.

You will lead risk assessments, review change controls, and support inspection readiness. A strong background in GxP CSV/CSA and cross‑functional collaboration is required, with travel to the SF office quarterly for

Qualifications

• Bachelor’s or Master’s degree in software, computer engineering, or technical field.
• 8+ years of experience in quality systems development and maintenance within clinical and commercial‑stage pharmaceutical or biotech companies.
• Experience with GxP computerized system validation/assurance (CSV/CSA) and system lifecycle management.
• Working knowledge of applicable electronic‑record, computerized‑system, data‑integrity, clinical‑practice, and pharmacovigilance requirements and guidance, including 21 CFR Part 11, FDA predicates, EU Annex 11, ICH GCP, and EU GVP.

Responsibilities

• Provide QA oversight of the GCP/GVP computer system validation lifecycle.
• Review risk assessments to determine scope of validation.
• Review IT change control and validation deliverables (protocols, test scripts, reports).
• Participate in periodic system and user reviews to identify and remediate gaps.
• Collaborate with IT and cross‑functional stakeholders to enforce validation requirements.

Skills

GxP CSV/CSA

QA lifecycle

Cross-functional collaboration

Communication skills

Attention to detail

AI governance (UX)

Travel

Education

Bachelor’s or Master’s in software/engineering

Job description

BridgeBio is seeking a Senior Manager, Computer System Validation (CSV), QA in California to oversee the validation lifecycle for GxP systems. You will partner with IT, QA, and business process owners to ensure systems remain compliant and validated throughout their lifecycles.

You will lead risk assessments, review change controls, and support inspection readiness. A strong background in GxP CSV/CSA and cross‑functional collaboration is required, with travel to the SF office quarterly for